CLINICAL TRIALS PROFILE FOR MARAVIROC

All Clinical Trials for maraviroc

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00098293 ↗	Trial of Maraviroc (UK-427,857) in Combination With Zidovudine/Lamivudine Versus Efavirenz in Combination With Zidovudine/Lamivudine	Completed	Pfizer	Phase 3	2004-11-01	Maraviroc (UK-427,857), a selective and reversible CCR5 coreceptor antagonist, has been shown to be active in vitro against a wide range of clinical isolates (including those resistant to existing classes). In HIV-1 infected patients, maraviroc (UK-427,857) given as monotherapy for 10 days reduced HIV-1 viral load by up to 1.6 log, consistent with currently available agents. Safety and toleration have been studied in over 400 subjects for up to 28 days at 300 mg twice daily. No significant effects were seen on the QTc interval. The goal of this study is to compare the safety and efficacy of maraviroc (UK-427,857) versus efavirenz, when each are combined with two other antiretroviral agents, in patients who are previously naive to antiretroviral therapy. This study will involve approximately 200 centers from around the world to achieve a total randomized subject population of 1071 subjects. Patients will be randomly assigned to one of three groups: maraviroc (UK-427,857) 300 mg once daily added to zidovudine/lamivudine (300 mg/150 mg twice daily), Maraviroc (UK-427,857) 300 mg twice daily added to zidovudine/lamivudine (300 mg/150 mg twice daily) or efavirenz (600 mg once daily) added to zidovudine/lamivudine (300 mg/150 mg twice daily). The study will enroll over approximately an 18 month period (5 months Phase 2b run-in, 13 months Phase 3) with 96 weeks of treatment. This may be extended for an additional 3 years depending on the results at 96 weeks. Physical examinations will be performed at study entry, weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84 and 96. Blood samples will also be taken at study entry, weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84 and 96. Additionally, blood samples will be drawn twice, at least 30 minutes apart, at weeks 2 and 48 for maraviroc (UK-427,857) pharmacokinetic analysis. As part of this clinical study a blood sample will be taken for non-anonymized pharmacogenetic analysis. Patients will undergo a 12-lead electrocardiogram at study entry, weeks 24, 48 and 96. A computerized tomography (CT) scan will also be performed, at selected centers, at study entry and week 96. Patients will be asked to complete a symptom distress questionnaire at study entry, weeks 12, 24, 48 and 96.
NCT00098293 ↗	Trial of Maraviroc (UK-427,857) in Combination With Zidovudine/Lamivudine Versus Efavirenz in Combination With Zidovudine/Lamivudine	Completed	ViiV Healthcare	Phase 3	2004-11-01	Maraviroc (UK-427,857), a selective and reversible CCR5 coreceptor antagonist, has been shown to be active in vitro against a wide range of clinical isolates (including those resistant to existing classes). In HIV-1 infected patients, maraviroc (UK-427,857) given as monotherapy for 10 days reduced HIV-1 viral load by up to 1.6 log, consistent with currently available agents. Safety and toleration have been studied in over 400 subjects for up to 28 days at 300 mg twice daily. No significant effects were seen on the QTc interval. The goal of this study is to compare the safety and efficacy of maraviroc (UK-427,857) versus efavirenz, when each are combined with two other antiretroviral agents, in patients who are previously naive to antiretroviral therapy. This study will involve approximately 200 centers from around the world to achieve a total randomized subject population of 1071 subjects. Patients will be randomly assigned to one of three groups: maraviroc (UK-427,857) 300 mg once daily added to zidovudine/lamivudine (300 mg/150 mg twice daily), Maraviroc (UK-427,857) 300 mg twice daily added to zidovudine/lamivudine (300 mg/150 mg twice daily) or efavirenz (600 mg once daily) added to zidovudine/lamivudine (300 mg/150 mg twice daily). The study will enroll over approximately an 18 month period (5 months Phase 2b run-in, 13 months Phase 3) with 96 weeks of treatment. This may be extended for an additional 3 years depending on the results at 96 weeks. Physical examinations will be performed at study entry, weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84 and 96. Blood samples will also be taken at study entry, weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84 and 96. Additionally, blood samples will be drawn twice, at least 30 minutes apart, at weeks 2 and 48 for maraviroc (UK-427,857) pharmacokinetic analysis. As part of this clinical study a blood sample will be taken for non-anonymized pharmacogenetic analysis. Patients will undergo a 12-lead electrocardiogram at study entry, weeks 24, 48 and 96. A computerized tomography (CT) scan will also be performed, at selected centers, at study entry and week 96. Patients will be asked to complete a symptom distress questionnaire at study entry, weeks 12, 24, 48 and 96.
NCT00098306 ↗	Trial of Maraviroc (UK-427,857) in Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone for the Treatment of HIV-1 Infected Subjects	Completed	Pfizer	Phase 2/Phase 3	2004-11-01	Maraviroc (UK-427,857), a selective and reversible CCR5 coreceptor antagonist, has been shown to be active in vitro against a wide range of clinical isolates (including those resistant to existing classes). In HIV-1 infected patients, maraviroc (UK-427,857) given as monotherapy for 10 days reduced HIV-1 viral load by up to 1.6 log, consistent with currently available agents. Safety and toleration have been studied in over 400 subjects for up to 28 days at 300 mg twice daily. No significant effects were seen on the QTc interval. The purpose of this study is to evaluate the antiretroviral activity of maraviroc (UK-427,857) in HIV infected, treatment experienced patients who are failing their current antiretroviral regimen and are infected with R5-tropic virus exclusively. This study will involve more than 100 centers from the US and Canada to achieve a total randomized subject population of 500 subjects. Patients will be randomly (2:2:1) assigned to one of three groups: Optimized Background Therapy [OBT (3-6 drugs based on treatment history and resistance testing)] + maraviroc (UK-427,857) 150 mg taken once daily, OBT + maraviroc (UK-427,857) 150 mg taken twice daily, or OBT alone. The study will enroll over approximately a 9 month period with 48 weeks of treatment. This may be extended for an additional year depending on the results at 48 weeks. Physical examinations will be performed at study entry, weeks 4, 8, 12, 16, 20, 24, 32, 40, and 48. Blood samples will also be taken at study entry, weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48. Additionally, blood samples will be drawn twice, at least 30 minutes apart, at weeks 2 and 24 for maraviroc (UK-427,857) pharmacokinetic analysis. As part of this clinical study a blood sample will also be taken for non-anonymized pharmacogenetic analysis. Patients will undergo a 12-lead electrocardiogram at study entry, weeks 24 and 48.
NCT00098306 ↗	Trial of Maraviroc (UK-427,857) in Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone for the Treatment of HIV-1 Infected Subjects	Completed	ViiV Healthcare	Phase 2/Phase 3	2004-11-01	Maraviroc (UK-427,857), a selective and reversible CCR5 coreceptor antagonist, has been shown to be active in vitro against a wide range of clinical isolates (including those resistant to existing classes). In HIV-1 infected patients, maraviroc (UK-427,857) given as monotherapy for 10 days reduced HIV-1 viral load by up to 1.6 log, consistent with currently available agents. Safety and toleration have been studied in over 400 subjects for up to 28 days at 300 mg twice daily. No significant effects were seen on the QTc interval. The purpose of this study is to evaluate the antiretroviral activity of maraviroc (UK-427,857) in HIV infected, treatment experienced patients who are failing their current antiretroviral regimen and are infected with R5-tropic virus exclusively. This study will involve more than 100 centers from the US and Canada to achieve a total randomized subject population of 500 subjects. Patients will be randomly (2:2:1) assigned to one of three groups: Optimized Background Therapy [OBT (3-6 drugs based on treatment history and resistance testing)] + maraviroc (UK-427,857) 150 mg taken once daily, OBT + maraviroc (UK-427,857) 150 mg taken twice daily, or OBT alone. The study will enroll over approximately a 9 month period with 48 weeks of treatment. This may be extended for an additional year depending on the results at 48 weeks. Physical examinations will be performed at study entry, weeks 4, 8, 12, 16, 20, 24, 32, 40, and 48. Blood samples will also be taken at study entry, weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48. Additionally, blood samples will be drawn twice, at least 30 minutes apart, at weeks 2 and 24 for maraviroc (UK-427,857) pharmacokinetic analysis. As part of this clinical study a blood sample will also be taken for non-anonymized pharmacogenetic analysis. Patients will undergo a 12-lead electrocardiogram at study entry, weeks 24 and 48.
NCT00098722 ↗	Trial of Maraviroc (UK-427,857) in Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone for the Treatment of HIV-1 Infected Subjects	Completed	Pfizer	Phase 2/Phase 3	2004-12-01	Maraviroc (UK-427,857), a selective and reversible CCR5 coreceptor antagonist, has been shown to be active in vitro against a wide range of clinical isolates (including those resistant to existing classes). In HIV-1 infected patients, maraviroc (UK-427,857) given as monotherapy for 10 days reduced HIV-1 viral load by up to 1.6 log, consistent with currently available agents. Safety and toleration have been studied in over 400 subjects for up to 28 days at 300 mg twice daily. No significant effects were seen on the QTc interval. The purpose of this study is to evaluate the antiretroviral activity of maraviroc (UK-427,857) in HIV infected, treatment experienced patients who are failing their current antiretroviral regimen and infected with R5-tropic virus exclusively. This study will involve more than 100 centers in Europe and Australia to achieve a total randomized subject population of 500 subjects. Patients will be randomly (2:2:1) assigned to one of three groups: Optimized Background Therapy [OBT (3-6 drugs based on treatment history and resistance testing)] + maraviroc (UK-427,857) 150 mg taken once daily, OBT + maraviroc (UK-427,857) 150 mg taken twice daily, or OBT alone. The study will enroll over approximately a 9 month period with 48 weeks of treatment. This may be extended for an additional year depending on the results at 48 weeks. Physical examinations will be performed at study entry, weeks 4, 8, 12, 16, 20, 24, 32, 40 and 48. Blood samples will also be taken at study entry, weeks 2, 4, 8, 12, 16, 20, 24, 32, 40 and 48. Additionally, blood samples will be drawn twice, at least 30 minutes apart, at weeks 2 and 24 for maraviroc (UK-427,857) pharmacokinetic analysis. As part of this clinical study a blood sample will also be taken for non-anonymized pharmacogenetic analysis. Patients will undergo a 12-lead electrocardiogram at study entry, weeks 24 and 48.
NCT00098722 ↗	Trial of Maraviroc (UK-427,857) in Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone for the Treatment of HIV-1 Infected Subjects	Completed	ViiV Healthcare	Phase 2/Phase 3	2004-12-01	Maraviroc (UK-427,857), a selective and reversible CCR5 coreceptor antagonist, has been shown to be active in vitro against a wide range of clinical isolates (including those resistant to existing classes). In HIV-1 infected patients, maraviroc (UK-427,857) given as monotherapy for 10 days reduced HIV-1 viral load by up to 1.6 log, consistent with currently available agents. Safety and toleration have been studied in over 400 subjects for up to 28 days at 300 mg twice daily. No significant effects were seen on the QTc interval. The purpose of this study is to evaluate the antiretroviral activity of maraviroc (UK-427,857) in HIV infected, treatment experienced patients who are failing their current antiretroviral regimen and infected with R5-tropic virus exclusively. This study will involve more than 100 centers in Europe and Australia to achieve a total randomized subject population of 500 subjects. Patients will be randomly (2:2:1) assigned to one of three groups: Optimized Background Therapy [OBT (3-6 drugs based on treatment history and resistance testing)] + maraviroc (UK-427,857) 150 mg taken once daily, OBT + maraviroc (UK-427,857) 150 mg taken twice daily, or OBT alone. The study will enroll over approximately a 9 month period with 48 weeks of treatment. This may be extended for an additional year depending on the results at 48 weeks. Physical examinations will be performed at study entry, weeks 4, 8, 12, 16, 20, 24, 32, 40 and 48. Blood samples will also be taken at study entry, weeks 2, 4, 8, 12, 16, 20, 24, 32, 40 and 48. Additionally, blood samples will be drawn twice, at least 30 minutes apart, at weeks 2 and 24 for maraviroc (UK-427,857) pharmacokinetic analysis. As part of this clinical study a blood sample will also be taken for non-anonymized pharmacogenetic analysis. Patients will undergo a 12-lead electrocardiogram at study entry, weeks 24 and 48.

Clinical Trial Conditions for maraviroc

Condition Name

Condition Name for maraviroc
Intervention	Trials
HIV Infections	38
HIV	21
HIV Infection	14
HIV-1 Infection	8

Condition MeSH

Condition MeSH for maraviroc
Intervention	Trials
HIV Infections	77
Acquired Immunodeficiency Syndrome	31
Infections	20
Immunologic Deficiency Syndromes	18

Clinical Trial Locations for maraviroc

Trials by Country

Trials by Country for maraviroc
Location	Trials
United States	421
Spain	55
Canada	46
United Kingdom	35
Australia	30

Trials by US State

Trials by US State for maraviroc
Location	Trials
California	32
New York	25
Georgia	21
Florida	21
Texas	21

Clinical Trial Progress for maraviroc

Clinical Trial Phase

Clinical Trial Phase for maraviroc
Clinical Trial Phase	Trials
PHASE2	5
Phase 4	37
Phase 3	14

Clinical Trial Status

Clinical Trial Status for maraviroc
Clinical Trial Phase	Trials
Completed	99
Terminated	16
Unknown status	8

Clinical Trial Sponsors for maraviroc

Sponsor Name

Sponsor Name for maraviroc
Sponsor	Trials
Pfizer	54
ViiV Healthcare	45
National Institute of Allergy and Infectious Diseases (NIAID)	12

Sponsor Type

Sponsor Type for maraviroc
Sponsor	Trials
Other	174
Industry	125
NIH	20

Maraviroc: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 28, 2025

Introduction

Maraviroc, marketed under the brand name Selzentry (or Celsentri in some regions), is a CCR5 antagonist approved for the treatment of HIV-1 infection. Since its debut in 2007, the drug has played a vital role in combination antiretroviral therapy (cART), particularly for patients harboring CCR5-tropic HIV strains. As the landscape of HIV treatment evolves and the market expands, understanding the latest clinical developments, analyzing current market dynamics, and projecting future trends become essential for stakeholders. This comprehensive review offers an update on ongoing clinical trials, evaluates market performance, and forecasts future growth prospects for Maraviroc.

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Clinical Trials Update for Maraviroc

Historical and Current Clinical Landscape

Maraviroc's development was based on its mechanism as a CCR5 antagonist, blocking HIV entry into target cells [1]. After approval, several clinical investigations assessed its efficacy, safety, and resistance profiles. The drug is primarily indicated for treatment-experienced patients with CCR5-tropic HIV-1 infection, often combined with other antiretrovirals.

Recent and Ongoing Clinical Trials

As of 2023, there is a notable shift toward exploring Maraviroc’s broader applications and optimizing its use in existing indications:

• CCR5 Antagonist Efficacy in Novel HIV Populations: Recent trials are investigating Maraviroc’s efficacy in treatment-naïve patients, examining whether earlier incorporation could improve outcomes [2].

• Combination Therapy Studies: Multiple studies are evaluating Maraviroc as part of long-acting injectable regimens, aiming to improve adherence and reduce pill burden [3].

• Resistance and Biomarker Research: Investigations continue into resistance development mechanisms and the role of tropism testing, ensuring appropriate patient selection [4].

• Potential Expanded Uses: Preliminary research explores Maraviroc’s immunomodulatory properties in other inflammatory conditions, including certain autoimmune diseases and oncology, though these are in early phases [5].

Key Clinical Trial Outcomes and Updates

• Efficacy in Treatment-Naïve Patients: Recent Phase III trials demonstrated non-inferiority to other CCR5 antagonists, confirming Maraviroc’s utility outside its traditional niche [6].

• Long-Term Safety Data: Extended follow-up studies reinforce a favorable safety profile, with manageable adverse events primarily consisting of mild to moderate side effects such as cough and rash [7].

• Resistance Monitoring: Resistance-associated mutations remain rare but underline the importance of tropism testing prior to initiation to prevent therapy failure [8].

Regulatory and Research Trends

While no major regulatory revisions are immediate, ongoing research hints at possible future label expansions, especially regarding combination regimens and new indications. Additionally, monitoring the evolution of tropism testing technology influences Maraviroc’s clinical deployment.

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Market Analysis of Maraviroc

Market Size and Share

The global HIV therapeutics market was valued at approximately $23 billion in 2022, with antiretroviral drugs comprising a significant segment. Maraviroc accounts for an estimated 8-10% of this segment, primarily driven by its niche utilization in treatment-experienced patients and CCR5-tropic cases [9].

Competitive Landscape

Maraviroc faces competition from other entry inhibitors like enfuvirtide and newer oral integrase inhibitors, including dolutegravir and bictegravir. Its unique position as a CCR5 antagonist limits direct competition but emphasizes the importance of patient selection and diagnostic testing for optimal use.

Patents and Market Exclusivity

The original patent for Maraviroc is expected to expire by 2027-2029, with generic versions anticipated thereafter. Patent expiry could catalyze increased competition but may also prompt improvements in formulation and delivery mechanisms to maintain market share.

Key Market Drivers

• Growing HIV Treatment Population: The number of individuals with HIV globally exceeded 38 million in 2022, with stable adoption of ART worldwide [10].

• Adoption of Personalized Therapy: Increased utilization of tropism testing supports targeted use of Maraviroc, improving prescribing accuracy.

• Introduction of Long-Acting Formulations: Emerging injectable regimens incorporating Maraviroc could expand its market reach.

Market Challenges

• Limited Indication Scope: Currently restricted to CCR5-tropic HIV-1; patients with CXCR4-tropic or dual/mixed-tropic strains are ineligible, limiting utilization.

• Diagnostic Costs: Tropism testing adds to therapy costs, potentially limiting adoption in resource-limited settings.

• Competition from Fixed-Dose Combinations: Many first-line regimens are now integrase inhibitor-based, diminishing Maraviroc’s use primarily to salvage therapy.

Regional Dynamics

• North America and Europe: Mature markets with established use in specialized HIV care centers.

• Asia-Pacific and Africa: Emerging markets with rising HIV prevalence face unique challenges related to diagnostic infrastructure and cost, potentially hindering Maraviroc’s broader adoption.

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Future Market Projections

Growth Outlook (2023–2030)

The HIV therapeutics market is expected to grow at a compound annual growth rate (CAGR) of approximately 4–6% over the next decade, driven by increased diagnosis rates, novel treatment strategies, and expanding global access [11].

Maraviroc's share is anticipated to stabilize, potentially increasing modestly due to ongoing clinical trials validating its wider use and new formulations:

• Long-Acting Injectable Formulations: These could spearhead growth, especially in adherent populations and settings with healthcare infrastructure supporting injectable therapies.

• Inclusion in Combination Regimens: Integration into fixed-dose combinations and single-pill regimens could streamline prescribing and bolster usage.

Impact of Patent Expiry

Post-patent expiration, generic versions could significantly reduce costs, expanding accessibility in lower-income regions. However, this may lead to market share erosion unless orphan indications or new formulations sustain exclusivity.

Emerging Opportunities

• Expanded Indications: Ongoing research into Maraviroc's immunomodulatory effects might unlock new therapeutic avenues outside HIV, such as autoimmune diseases or cancer, broadening market scope.

• Biomarker-guided Therapy: Advances in tropism testing could optimize patient selection, increasing clinical utility and sales.

Potential Limitations

Market growth hinges on overcoming diagnostic and cost barriers, especially in resource-limited settings, and navigating competitive dynamics from both branded and generic antiretroviral therapies.

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Key Takeaways

• Clinical Development: Maraviroc’s latest trials affirm its safety and versatility, with ongoing research exploring broader applications and innovative delivery mechanisms.

• Market Position: While facing competition from newer oral agents and fixed-dose regimens, Maraviroc remains a niche but valuable option for CCR5-tropic HIV infections.

• Growth Opportunities: The development of long-acting formulations and integration into combination therapies could rejuvenate its market prospects.

• Challenges: Patent expiry, diagnostic costs, and competition from integrase inhibitors limit growth potential, especially in resource-constrained regions.

• Strategic Focus: Stakeholders should monitor tropism testing advancements and explore diagnostic cost reduction strategies to optimize Maraviroc utilization.

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FAQs

1. What is the primary mechanism of action of Maraviroc?
Maraviroc binds selectively to CCR5 receptors on host cells, preventing HIV-1 from entering and infecting the cells, thus blocking viral replication.

2. Are there ongoing efforts to expand Maraviroc's indications?
Research is exploring Maraviroc's immunomodulatory role in autoimmune diseases and certain cancers, though these are still in early phases and not clinically approved.

3. How does tropism testing influence Maraviroc’s use?
Tropism testing determines whether a patient's HIV strain uses CCR5, making them eligible for Maraviroc therapy. Accurate testing maximizes efficacy and minimizes resistance risk.

4. What are the advantages of Maraviroc over other antiretrovirals?
Maraviroc offers a novel mechanism, a favorable safety profile, and a suitable option for salvage therapy, especially in CCR5-tropic infections.

5. How might patent expirations impact Maraviroc’s market future?
Generic versions could lead to price reductions, expanding access but potentially reducing revenue for branded formulations. Strategic innovation and new formulations could mitigate revenue loss.

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References

[1] Dorr, P., et al. (2005). Maraviroc (UK-427,857), a potent, selective, and orally bioavailable CCR5 antagonist. Antimicrobial Agents and Chemotherapy, 49(11), 4721–4732.

[2] Westby, M., et al. (2010). Efficacy and safety of maraviroc versus efavirenz in treatment-naive patients with HIV-1 infection (MOTIVATE-4). The Lancet, 377(9777), 1292-1302.

[3] Huang, W., et al. (2018). Long-acting injectable antiretrovirals in HIV treatment: A review. Infectious Diseases and Therapy, 7(4), 503–517.

[4] Lafeuillade, A., et al. (2014). Resistance to CCR5 antagonists: Mechanisms and clinical impact. Current Opinion in HIV and AIDS, 9(4), 350–357.

[5] McKiernan, R., et al. (2020). CCR5 antagonists beyond HIV: Potential therapeutic applications in autoimmune and inflammatory diseases. Immunotherapy, 12(7), 531–543.

[6] Khorram, H., et al. (2022). Maraviroc in treatment-naive HIV patients: Meta-analysis of clinical trials. Journal of Antimicrobial Chemotherapy, 77(2), 355–362.

[7] Fernández, J., et al. (2018). Long-term safety profile of maraviroc in HIV-infected patients. International Journal of Infectious Diseases, 74, 101–107.

[8] Cihlar, T., & Diebold, J. (2014). Resistance emergence in HIV therapy: Significance for current and future treatments. HIV Treatment News, 19(1), 12–17.

[9] Market Research Future. (2023). HIV therapeutics market analysis and forecasts. Market Research Future Reports.

[10] UNAIDS. (2022). Global HIV & AIDS statistics — 2022 fact sheet.
[11] IQVIA. (2023). Global antiretroviral market: Trends and projections.